Opioid Use DisorderPhase 4NCT05704543

Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations

A Phase 4 study testing Buprenorphine Extended-Release Injection in people with Opioid Use Disorder, run by Indivior Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Extended-release buprenorphine (SUBLOCADE®) injection is currently approved for subcutaneous administration in the abdomen for treatment of opioid use disorder (OUD). Having alternative injection sites is desirable to provide additional flexibility to patients, particularly for those who may prefer less visible or… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Opioid Use Disorder
What is being tested?: Buprenorphine Extended-Release Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 132 participants
Where: 6 sitesUnited States
Study dates: 1 Mar 2023to 1 Nov 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed the informed consent form (ICF) and have the ability to comply with the requirements and restrictions listed therein.
Sex: male or female.
Between the ages of 18 and 65 years inclusive, at the time of signing the ICF.
Currently meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for moderate or severe opioid use disorder (OUD), or documented history of moderate to severe OUD and receiving/stabilized on medicine for opioid use disorder (MOUD).
Body mass index: ≥ 18.0 to ≤ 33.0 kg/m^2.
New to treatment and seeking MOUD, or currently prescribed transmucosal (TM) buprenorphine (BUP) for OUD at the dose of 12 mg daily or can dose adjust to 12 mg daily.
Agree not to take any BUP-containing products, other than those administered for the current study, throughout the duration of the study.

Who cannot join

Has current diagnosis, other than OUD, requiring chronic opioid treatment.
Has concurrent primary substance use disorder, as defined by DSM-5 criteria, other than opioid, tobacco, cannabis, or mild to moderate alcohol use disorders.
Has target areas unsuitable for subcutaneous injections or evaluation of injections site (eg, nodules, scarring, lesions, excessive pigment) in the areas designated for possible injection in the study.
Has had significant traumatic injury or major surgical procedure (as defined by the investigator) within 30 days prior to the first dose of SUBLOCADE or still recovering from prior such injury or surgery.
Known personal and/or family history of congenital QT prolongation, or taking Class IA antiarrhythmic medications (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (eg, sotalol, amiodarone) or other medications that prolong the QT interval. Known family history of sudden unexplained death.
Currently taking (within the 30 days prior to signing the ICF) prescription or over-the-counter medications that are clinically relevant CYP 3A4 or CYP 2C8 inducers or inhibitors (eg, rifampin, azole antifungals [eg, ketoconazole], macrolide antibiotics [eg, erythromycin]).

Show all 14Show fewer

Has history of suicidal ideation within 30 days prior to informed consent or history of a suicide attempt in the 6 months prior to informed consent.
Has any active medical condition, or psychiatric illness, or social/legal situation (including court order requiring treatment for OUD), or organ disease, or concurrent medication/treatment that may compromise participant safety, interfere with study endpoints, or limit compliance with study requirements, or compromise the ability of the participant to provide written informed consent.
Moderate or severe hepatic impairment (Child-Pugh B or C).
Has known allergy or hypersensitivity to BUP or any component of the ATRIGEL Delivery System.
Concurrent or has had prior treatment with any BUP long-acting injectable product (eg, SUBLOCADE) in the past 3 years prior to consent; or treatment with depot naltrexone within the 3 months prior to consent.
Treatment with another investigational agent within 30 days prior to Screening or enrollment in another clinical study (except for an observational study).
Concurrent treatment with medications contraindicated for use with BUP as per local prescribing information.
Is a member of site staff, has a financial interest in Indivior, or is an immediate family member of anyone directly involved in the study (ie, site staff or Indivior employee).

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

InSite Clinical Research, LLC
DeSoto, Texas, 75115
Research Centers of America
Hollywood, Florida, 33024
Miami Lakes Medical Research
Miami Lakes, Florida, 33016
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma, 73112
Pillar Clinical Research, LLC
Richardson, Texas, 75080
Artemis Institute for Clinical Research
San Diego, California, 92103

Other trials in United States

About this study

Official title: A Single-Dose Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of SUBLOCADE at Alternative Injection Locations in Adults

The primary objective of this study is to assess the relative bioavailability of extended-release buprenorphine when administered at alternative injection locations (test treatments), in comparison to the abdomen (reference treatment).

Conditions: Opioid Use Disorder
Being tested: Buprenorphine Extended-Release Injection
Keywords: medicine for opioid use disorder (MOUD)
Medical subject headings: Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Buprenorphine Extended-Release InjectionDrug
Also called SUBLOCADE®
Administered as a subcutaneous injection.

Study groups in NCT05704543
Study group	Role	What they receive
Extended-release Buprenorphine: Abdomen	Active comparator	Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1. Receives: Drug: Buprenorphine Extended-Release Injection
Extended-release Buprenorphine: Upper Arm	Experimental	Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1. Receives: Drug: Buprenorphine Extended-Release Injection
Extended-release Buprenorphine: Buttocks	Experimental	Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1. Receives: Drug: Buprenorphine Extended-Release Injection
Extended-release Buprenorphine: Thigh	Experimental	Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1. Receives: Drug: Buprenorphine Extended-Release Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration-time Curve From Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine
Measured: Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29
Maximum Observed Plasma Concentration (Cmax) of Buprenorphine
Measured: Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29

Secondary outcomes (5)

Participants With Treatment-emergent Adverse Events
Measured: 28 days
Number of Participants With Treatment-emergent Adverse Events Identified as Injection Site Reactions
Measured: 28 days
Number of Participants With Treatment-emergent Serious Adverse Events
Measured: 28 days
Injection Site Grading
Injection sites will be assessed for pain, tenderness, erythema/redness, induration, or swelling. Local injection site tolerability will be assigned a severity grade, including none (grade 0), mild (grade 1), moderate (grade 2), severe (grade 3), or potentially life-threatening (grade 4) utilizing the Injection Site Grading Scale.
Measured: Day 1 at 10 minutes and 2 hours post dosing
Injection Site Pain
Measured on a 100 mm visual analog scale (VAS), where 0 represents no pain and 100 represents maximum pain.
Measured: Day 1 at 1, 5, 10, 15, and 30 minutes post dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20231 Nov 2023

First posted30 Jan 2023
Study start1 Mar 2023
Primary completion1 Nov 2023
Study completion1 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05704543
Sponsor's protocol ID: INDV-6000-405
Status last verified: Dec 2024
First submitted: 19 Jan 2023
Last updated: 7 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Laffont CM, Lapeyra O, Mangal D, Dobbins R. A Single-Dose Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of Monthly Extended-Release Buprenorphine at Alternative Injection Locations in Adult Participants with Opioid Use Disorder. Clin Drug Investig. 2024 Dec;44(12):939-949. doi: 10.1007/s40261-024-01406-7. Epub 2024 Nov 14.
PubMed 39543001

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of SUBLOCADE at Alternative Injection Locations in Adults
ClinicalTrials.gov ID: NCT05704543
Acronym / sponsor ID: INDV-6000-405
Conditions: Opioid Use Disorder
Keywords: medicine for opioid use disorder (MOUD)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 132 participants (actual)
Lead sponsor: Indivior Inc.Industry (pharma, biotech, devices)
Study start: 1 Mar 2023 (actual)
Primary completion: 1 Nov 2023 (actual)
Study completion: 1 Nov 2023 (actual)
First posted: 30 Jan 2023 (actual)
Results: Posted 7 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Extended-release Buprenorphine: Abdomen	Active comparator	Drug: Buprenorphine Extended-Release InjectionParticipants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1.
Extended-release Buprenorphine: Upper Arm	Experimental	Drug: Buprenorphine Extended-Release InjectionParticipants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1.
Extended-release Buprenorphine: Buttocks	Experimental	Drug: Buprenorphine Extended-Release InjectionParticipants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.
Extended-release Buprenorphine: Thigh	Experimental	Drug: Buprenorphine Extended-Release InjectionParticipants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Signed the informed consent form (ICF) and have the ability to comply with the requirements and restrictions listed therein.
Sex: male or female.
Between the ages of 18 and 65 years inclusive, at the time of signing the ICF.
Currently meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for moderate or severe opioid use disorder (OUD), or documented history of moderate to severe OUD and receiving/stabilized on medicine for opioid use disorder (MOUD).
Body mass index: ≥ 18.0 to ≤ 33.0 kg/m^2.

Key exclusion criteria (14 listed)

Has current diagnosis, other than OUD, requiring chronic opioid treatment.
Has concurrent primary substance use disorder, as defined by DSM-5 criteria, other than opioid, tobacco, cannabis, or mild to moderate alcohol use disorders.
Has target areas unsuitable for subcutaneous injections or evaluation of injections site (eg, nodules, scarring, lesions, excessive pigment) in the areas designated for possible injection in the study.
Has had significant traumatic injury or major surgical procedure (as defined by the investigator) within 30 days prior to the first dose of SUBLOCADE or still recovering from prior such injury or surgery.
Known personal and/or family history of congenital QT prolongation, or taking Class IA antiarrhythmic medications (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (eg, sotalol, amiodarone) or other medications that prolong the QT interval. Known family history of sudden unexplained death.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Buprenorphine Extended-Release InjectionAlso: SUBLOCADE®Administered as a subcutaneous injection.	Drug	Extended-release Buprenorphine: Abdomen, Extended-release Buprenorphine: Buttocks, Extended-release Buprenorphine: Thigh, Extended-release Buprenorphine: Upper Arm

Primary outcome

Area Under the Plasma Concentration-time Curve From Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine
Time frame: Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29
Maximum Observed Plasma Concentration (Cmax) of Buprenorphine
Time frame: Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29

5 secondary outcomes

Participants With Treatment-emergent Adverse Events
Time frame: 28 days
Number of Participants With Treatment-emergent Adverse Events Identified as Injection Site Reactions
Time frame: 28 days
Number of Participants With Treatment-emergent Serious Adverse Events
Time frame: 28 days
Injection Site Grading
Time frame: Day 1 at 10 minutes and 2 hours post dosing
Injection Site Pain
Time frame: Day 1 at 1, 5, 10, 15, and 30 minutes post dosing

Results and safety

Results posted to the registry on 7 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Extended-release Buprenorphine: Abdomen	22	20
Extended-release Buprenorphine: Upper Arm	21	18
Extended-release Buprenorphine: Buttocks	22	22
Extended-release Buprenorphine: Thigh	23	21

Primary outcome: Area Under the Plasma Concentration-time Curve From Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine

Time frame: Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Extended-release Buprenorphine: Abdomen n = 22	Extended-release Buprenorphine: Upper Arm n = 17	Extended-release Buprenorphine: Buttocks n = 22	Extended-release Buprenorphine: Thigh n = 21
Value	1640 (41.8)	1720 (57.4)	1570 (42.7)	1870 (56.2)

Population analysed: Pharmacokinetic Evaluable Analysis Set

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Buprenorphine

Measure	Extended-release Buprenorphine: Abdomen n = 22	Extended-release Buprenorphine: Upper Arm n = 20	Extended-release Buprenorphine: Buttocks n = 22	Extended-release Buprenorphine: Thigh n = 21
Value	6.61 (46.9)	9.17 (85.8)	7.11 (39.7)	10.1 (73.2)

Population analysed: Pharmacokinetic Evaluable Analysis Set

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 86 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-injection (Run-In Period)	0 of 132 (0%)	26 of 132 (19.7%)	0 of 132
Extended-release Buprenorphine: Abdomen (Post-injection)	0 of 22 (0%)	5 of 22 (22.7%)	0 of 22
Extended-release Buprenorphine: Upper Arm (Post-injection)	0 of 21 (0%)	3 of 21 (14.3%)	0 of 21
Extended-release Buprenorphine: Buttocks (Post-injection)	0 of 22 (0%)	4 of 22 (18.2%)	0 of 22
Extended-release Buprenorphine: Thigh (Post-injection)	0 of 23 (0%)	2 of 23 (8.7%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39543001Laffont CM, Lapeyra O, Mangal D, Dobbins R. A Single-Dose Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of Monthly Extended-Release Buprenorphine at Alternative Injection Locations in Adult Participants with Opioid Use Disorder. Clin Drug Investig. 2024 Dec;44(12):939-949. doi: 10.1007/s40261-024-01406-7. Epub 2024 Nov 14.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Director Clinical Development study director

Indivior Inc.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Buprenorphine Extended-Release Injection in people with Opioid Use Disorder, run by Indivior Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Plasma Concentration-time Curve From Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine (time frame: Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05704543, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.